Comparison of Electroacupuncture to Mirabegron for Treatment of Overactive Bladder

NCT03087578 | Withdrawn

• 1 other identifier: UHClevelandMC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares electroacupuncture to mirabegron for treatment of overactive bladder (OAB) symptoms in women who have failed treatment with anticholingeric therapy.

Conditions

Overactive Bladder

Keywords

overactive bladder, acupuncture

Outcome Measures

Primary Outcomes (6)

• Difference in Incontinence Impact Questionnaire (IIQ-7) scores

  change in IIQ-7 scores before and after initiation of treatment

  at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group

• Difference in Overactive Bladder Symptom Score (OABSS)

  change in OABSS before and after initiation of treatment

  at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group

• Urogenital Distress Inventory (UDI-6) scores

  change in UDI-6 scores before and after initiation of treatment

  at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group

• Differences in daytime frequency

  before and after treatment

  at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group

• incontinence episodes

  change in number of incontinence episodes before and after treatment

  at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group

• Nocturia

  change in number of nocturia episodes before and after treatment

  at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group

Secondary Outcomes (1)

• Recurrence/worsening of symptoms

  at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group

Study Arms (2)

EA

EXPERIMENTAL

Patients undergoing electroacupuncture weekly for 6 weeks for 30 minutes/session.

Other: electroacupncture

Medication

ACTIVE COMPARATOR

Patients will receive 50 mg of mirabegron daily for 6 weeks. Patients may continue to take this medication after the study if they have improvement in symptoms.

Drug: Mirabegron 50 MG [Myrbetriq]

Interventions

electroacupncture OTHER

Patients will receive electroacupuncture treatment for 30 minutes per weekly session for 6 weeks.

EA

Mirabegron 50 MG [Myrbetriq] DRUG

Patients will receive 50 mg of mirabegron daily for 6 weeks.

Medication

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients must be 18 years or older as well as willing and able to provide informed consent
• Patients with documented symptoms of overactive bladder including: urgency, frequency \>7 times per day, nocturia, urgency incontinence for at least 6 months
• Patients who have failed at least one anti-cholinergic medication defined as no change or unsatisfactory improvement in symptom severity after 6 weeks of a daily regimen

You may not qualify if:

• Patients younger than 18 years,
• Patients unable or unwilling to provide informed consent,
• Patients who are illiterate,
• Patients who are non-English speaking or reading,
• Patients with a current urinary tract infection
• Patients with a history of interstitial cystitis
• Patients who have a history of a bleeding disorder
• Patients who are currently on chronic anti-coagulation
• Patients who are have taken mirabegron in the past or are currently using it
• Patients currently undergoing acupuncture treatment for a different condition
• Patients who are currently undergoing pelvic floor physical therapy
• Patients who are currently undergoing or will undergo treatment for a urologic or gynecologic malignancy
• Patients who are currently pregnant
• Patients with an implanted pacemaker or AICD
• Patients with a history of uncontrolled or poorly controlled hypertension

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Hargreaves E, Baker K, Barry G, Harding C, Zhang Y, Kandala NB, Zhang X, Kernohan A, Clarkson CE. Acupuncture for treating overactive bladder in adults. Cochrane Database Syst Rev. 2022 Sep 23;9(9):CD013519. doi: 10.1002/14651858.CD013519.pub2.

  PMID: 36148895 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 22, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: September 30, 2018
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)